Trial Outcomes & Findings for Prospective Clinical Trial to Evaluate the Safety and Effectiveness of the IOL (NCT NCT03451786)
NCT ID: NCT03451786
Last Updated: 2023-04-11
Results Overview
Proportion of subjects achieving BCDVA 0.3 logMAR or better
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
369 participants
Primary outcome timeframe
postoperative days 330-420
Results posted on
2023-04-11
Participant Flow
Participant milestones
| Measure |
Treatment Group
IOL: Intraocular lens
|
|---|---|
|
Overall Study
STARTED
|
369
|
|
Overall Study
COMPLETED
|
310
|
|
Overall Study
NOT COMPLETED
|
59
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Clinical Trial to Evaluate the Safety and Effectiveness of the IOL
Baseline characteristics by cohort
| Measure |
Treatment Group
n=339 Participants
IOL: Intraocular lens
|
|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 8.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
208 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
321 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
299 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: postoperative days 330-420Proportion of subjects achieving BCDVA 0.3 logMAR or better
Outcome measures
| Measure |
Treatment Group
n=310 Participants
IOL: Intraocular lens
|
|---|---|
|
Best Corrected Distance Visual Acuity
|
308 Participants
|
Adverse Events
Treatment Group
Serious events: 13 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group
n=339 participants at risk
IOL: Intraocular lens
|
|---|---|
|
Eye disorders
Retinal detachment
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Eye disorders
Anterior capsular contraction
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute myocardial infraction
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
General disorders
Adverse drug reaction
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Cardiac disorders
Aortic aneurysm
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Post procedural complication
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Post procedural hemorrhage
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma metastatic
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal compression fracture
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
General disorders
Unevaluable event
|
0.29%
1/339 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Chronic kidney disease
|
0.29%
1/339 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Treatment Group
n=339 participants at risk
IOL: Intraocular lens
|
|---|---|
|
Eye disorders
cystoid macular edema
|
2.1%
7/339 • Number of events 7 • 1 year
|
|
Eye disorders
Intraocular pressure increased
|
7.4%
25/339 • Number of events 25 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place